Keeping Up with Progress in Mobile Medical Apps

The Justice Department says it has reached a settlement to ensure prisoners at the Piedmont Regional Jail in Farmville receive appropriate medical and mental health care. Officials say the department launched an investigation in March 2011 into allegations that the jail was not providing prisoners with constitutionally adequate medical care. Friday’s Photos of the day The department says its investigation found deficiencies in medical and mental health care at the jail exposed prisoners to an unreasonable risk of serious harm. Among the findings were inadequate staffing, insufficient procedures to screen and assess medical and mental health problems, and the absence of a chronic care program to treat conditions such as seizures, heart diseases and high blood pressure, the department said. The agreement announced Friday requires the jail to employ adequate medical and mental health personnel, perform timely screening and appropriate health assessments and establish a chronic care program, among other things. Jail officials also must track the performance of medical and mental health improvement efforts. It also must work with an independent monitor to implement the changes described in the agreement and to evaluate the jails success in effecting meaningful reform. Piedmont Regional Jail is a minimum to high-security facility that serves Amelia, Buckingham, Cumberland, Lunenburg, Nottoway and Prince Edward counties. It houses more than 700 male and female inmates. Officials with the jail did not immediately return a phone message seeking comment on Saturday. Copyright 2013 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

The draft guidance for mobile medical apps, published in July 2011, elicited more than 130 public comments that the FDA reviewed and considered when writing the final guidance. “Most were positive; people generally liked the draft proposal and understood which types of mobile medical apps we would regulate,” says Bakul Patel, M.S., MBA, senior policy advisor to the director of FDA’s Center for Devices and Radiological Health. However, some who commented asked for more examples of what would not fall within the focus of FDA’s regulatory oversighta suggestion incorporated in the final guidance just issued. Patel explained, for example, that FDA would regulate a mobile medical app that helps measure blood pressure by controlling the inflation and deflation of a blood pressure cuff (a blood pressure monitor), just as it regulates traditional devices that measure blood pressure. A false reading by either blood pressure device would deliver a false diagnosis and perhaps even lead to treatment that could endanger patients. However, although a mobile app that doctors or patients use to log and track trends with their blood pressure is a medical device, as explained in the final mobile medical app guidance, such mobile apps would not fall within the current focus of FDA’s regulatory oversight. Similarly, mobile medical apps that recommend calorie or carbohydrate intakes to people who track what they eat also are not within the current focus of FDA’s regulatory oversight. While such mobile apps may have health implications, FDA believes the risks posed by these devices are low and such apps can empower patients to be more engaged in their health care. In the final mobile medical apps guidance, FDA clarifies that its mobile medical apps policy does not apply to the use of smartphones or tablets themselves. Providers of mobile medical apps, such as the iTunes app store, would not be treated as medical device manufacturers. back to top A Growing Trend The mobile app market is anticipated to grow 25 percent annually for some time, according to the market research firm Kalorama Information; companies are investing record amounts in developing new health apps. Consumers will be finding more and more options from which to choose. FDA intends to stay current with the expertise needed to evaluate mobile medical apps for which safe use and accuracy are critical to public health by hiring additional skilled engineers, including software engineers, and medical officers with device expertise. FDA also works closely with experts in academia and is now reviewing its current practices involved in evaluating software used in mobile medical apps.